Psychological StressNCT00962273
The Pandemic Stress Vaccine: A Resource to Enhance the Resilience of Healthcare Workers Facing an Infectious Outbreak
A study testing Interactive computerized learning resource and Didactic computerized learning resource in people with Psychological Stress, run by Mount Sinai Hospital, Canada at 1 site in Canada.
Trial summary
The purpose of this study is to determine the effects of an interactive, computerized learning resource designed to increase resilience in hospital-based health care workers preparing for an influenza pandemic. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Psychological Stress
- What is being tested?
- Interactive computerized learning resource and Didactic computerized learning resource
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 118 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2009to Jul 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- employee or professional staff of a hospital
Who cannot join
- unable to read and write English
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Pandemic Stress Vaccine: Randomized Controlled Trial of an Educational Resource to Enhance the Resilience of Healthcare Workers Facing an Infectious Outbreak
The purpose of this study is to determine the effects of an interactive, computerized learning resource designed to increase resilience in hospital-based health care workers preparing for an influenza pandemic. The effects of the learning resource will be compared to a non-interactive learning resource condition and a control condition. It is hypothesized that (a) online pandemic-related education reduces absenteeism and interpersonal problems for healthcare workers (HCWs), and improves their pandemic self-efficacy in the short and long-term, and (b) an interactive format for online education is necessary for its benefits.
- Conditions
- Psychological Stress
- Being tested
- Interactive computerized learning resource, Didactic computerized learning resource
- Keywords
- health personnel, communicable diseases, stress, psychological, resilience, psychological, disaster planning, education, online
- Medical subject headings
- Stress, Psychological, Communicable Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interactive computerized learning resourceBehavioural
In a series of interactive scenarios, participants can "see" themselves in stressful work situations that could arise during an influenza pandemic and reflect on effective ways to work out personal and interpersonal difficulties.
Didactic computerized learning resourceBehavioural
In a non-interactive format (i.e., a series of audio presentations with accompanying PowerPoint-type slides) participants are given information on how to handle stressful work situations that could arise during an influenza pandemic.
| Study group | Role | What they receive |
|---|---|---|
| Pandemic Stress Vaccine - Interactive | Experimental | Not described Receives: Behavioral: Interactive computerized learning resource |
| Pandemic Stress Vaccine - Didactic | Active comparator | Not described Receives: Behavioral: Didactic computerized learning resource |
| Wait list | No intervention | Some participants are assigned to an eight week waiting condition prior to the course commencing. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absenteeism
Measured: 32 weeks
Secondary outcomes (2)
Pandemic self-efficacy
Measured: 32 weeks
Interpersonal problems
Measured: 32 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2009 (estimated)
- Study startOct 2009
- Primary completionJul 2010
- Study completionJul 2010
Why it stopped: low participation and retention rates
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Psychological StressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 118 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mount Sinai Hospital, Canada
- Sponsor type
- University, hospital or other
- Investigators
- William J. Lancee, Ph.D., Principal investigator, MOUNT SINAI HOSPITALRobert G. Maunder, M.D., Principal investigator, MOUNT SINAI HOSPITAL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00962273
- Sponsor's protocol ID
- 09-0133-E
- Status last verified
- Aug 2010
- First submitted
- 18 Aug 2009
- Last updated
- 19 Aug 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Maunder RG, Lancee WJ, Balderson KE, Bennett JP, Borgundvaag B, Evans S, Fernandes CM, Goldbloom DS, Gupta M, Hunter JJ, McGillis Hall L, Nagle LM, Pain C, Peczeniuk SS, Raymond G, Read N, Rourke SB, Steinberg RJ, Stewart TE, VanDeVelde-Coke S, Veldhorst GG, Wasylenki DA. Long-term psychological and occupational effects of providing hospital healthcare during SARS outbreak. Emerg Infect Dis. 2006 Dec;12(12):1924-32. doi: 10.3201/eid1212.060584.
PubMed 17326946
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Pandemic Stress Vaccine: Randomized Controlled Trial of an Educational Resource to Enhance the Resilience of Healthcare Workers Facing an Infectious Outbreak
- ClinicalTrials.gov ID
- NCT00962273
- Acronym / sponsor ID
- 09-0133-E
- Conditions
- Psychological Stress
- Keywords
- health personnel, communicable diseases, stress, psychological, resilience, psychological, disaster planning, education, online
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: low participation and retention rates
- Enrolment
- 118 participants (actual)
- Lead sponsor
- Mount Sinai Hospital, CanadaUniversity, hospital or other
- Study start
- Oct 2009
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 19 Aug 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the effects of an interactive, computerized learning resource designed to increase resilience in hospital-based health care workers preparing for an influenza pandemic. The effects of the learning resource will be compared to a non-interactive learning resource condition and a control condition. It is hypothesized that (a) online pandemic-related education reduces absenteeism and interpersonal problems for healthcare workers (HCWs), and improves their pandemic self-efficacy in the short and long-term, and (b) an interactive format for online education is necessary for its benefits.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Pandemic Stress Vaccine - Interactive | Experimental | Behavioral: Interactive computerized learning resource |
| Pandemic Stress Vaccine - Didactic | Active comparator | Behavioral: Didactic computerized learning resource |
| Wait list | No intervention | –Some participants are assigned to an eight week waiting condition prior to the course commencing. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- employee or professional staff of a hospital
Key exclusion criteria (1 listed)
- unable to read and write English
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Interactive computerized learning resourceIn a series of interactive scenarios, participants can "see" themselves in stressful work situations that could arise during an influenza pandemic and reflect on effective ways to work out personal and interpersonal difficulties. | Behavioural | Pandemic Stress Vaccine - Interactive |
| Didactic computerized learning resourceIn a non-interactive format (i.e., a series of audio presentations with accompanying PowerPoint-type slides) participants are given information on how to handle stressful work situations that could arise during an influenza pandemic. | Behavioural | Pandemic Stress Vaccine - Didactic |
Primary outcome
Absenteeism
Time frame: 32 weeks
2 secondary outcomes
Pandemic self-efficacy
Time frame: 32 weeks
Interpersonal problems
Time frame: 32 weeks
Results and safety
The study was stopped early (reason given: low participation and retention rates). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2010.
- Results publication: PubMed 17326946Maunder RG, Lancee WJ, Balderson KE, Bennett JP, Borgundvaag B, Evans S, Fernandes CM, Goldbloom DS, Gupta M, Hunter JJ, McGillis Hall L, Nagle LM, Pain C, Peczeniuk SS, Raymond G, Read N, Rourke SB, Steinberg RJ, Stewart TE, VanDeVelde-Coke S, Veldhorst GG, Wasylenki DA. Long-term psychological and occupational effects of providing hospital healthcare during SARS outbreak. Emerg Infect Dis. 2006 Dec;12(12):1924-32. doi: 10.3201/eid1212.060584.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
William J. Lancee, Ph.D. principal investigator
MOUNT SINAI HOSPITAL
Robert G. Maunder, M.D. principal investigator
MOUNT SINAI HOSPITAL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interactive computerized learning resource and Didactic computerized learning resource in people with Psychological Stress, run by Mount Sinai Hospital, Canada at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 19 Aug 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: low participation and retention rates). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Absenteeism (time frame: 32 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00962273, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2010.